Biomarker Sample Ops Lead for Clinical Trials

Us Tech Solutions; South San Francisco (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

US Tech Solutions in South San Francisco seeks a Biomarker Sample Operations Manager for a 2-year contract to coordinate collection, transfer and testing of clinical trial biomarker specimens, ensuring compliance with ICH/GCP and project timelines.

You will work closely with clinical operations, project managers and laboratory managers to ensure timely shipments, accurate data transfer to databases, and ongoing process improvements, while developing SME capabilities with minimal supervision.

Qualifications

• Master’s degree with 3+ years PM experience in oncology/biomarkers or clinical trials.
• Bachelor’s degree with 4+ years PM experience in oncology/biomarkers or clinical trials.
• Excellent oral and written communication in English.
• PMP certification is a plus.
• Clinical trial experience and scientific background in oncology.

Responsibilities

• Plan, organize and oversee the collection and shipping of bio-samples to assay laboratories.
• Lead delivery of bio-sample data in line with study timelines and data transfer to databases.
• Oversee sample handling, processing, transport, storage and disposal per procedures.
• Review study documents and create edit checks for sample types.
• Manage relationships with laboratory vendors and ensure SLA adherence.
• Review lab vendor invoices to confirm completed work.
• Assist with contracts and vendor oversight in compliance procedures.
• Contribute to development of a sample tracking system with IT.
• Ensure compliance with ICH/GCP and bio-storage procedures.
• Mentor team members and develop SME capabilities.
• Support process improvement initiatives and internal training.

Skills

Excellent communication

Time management

Organizational skills

Education

Master’s degree with 3+ years PM experience in oncology/biomarkers or clinical trials

Bachelor’s degree with 4+ years PM experience in oncology/biomarkers or clinical trials

Tools

MS Office (Excel, Word, PowerPoint)

Job description

US Tech Solutions in South San Francisco seeks a Biomarker Sample Operations Manager for a 2-year contract to coordinate collection, transfer and testing of clinical trial biomarker specimens, ensuring compliance with ICH/GCP and project timelines.

You will work closely with clinical operations, project managers and laboratory managers to ensure timely shipments, accurate data transfer to databases, and ongoing process improvements, while developing SME capabilities with minimal supervision.